Regulatory Affairs Executive

4 hours ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

**Headquartered: US**:

- **Position: Regional**:

- **Product Porfolio: Medical Devices**:

- **Reporting to: Regulatory Affairs Manager**

**MAIN RESPONSIBILITIES**:

- Facilitate regulatory affairs activities related to regulatory submissions, annual reports, registrations, and listings while ensuring compliance with relevant medical device regulations, guidances, and standards in applicable countries.
- Work with other departments to communicate regulatory submission requirements when documents are needed.
- Assist in preparing responses to regulatory authorities' questions within assigned timelines.
- Develop solutions to regulatory issues during pre-market activities and establish partnerships for effective implementation and resolution.
- Drive regulatory affairs and quality assurance activities to ensure timely registration of products and life cycle management while minimizing risks associated with post-marketing surveillance.
- Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
- Keep up-to-date with changes in regulatory requirements in relevant countries by monitoring relevant regulatory changes.
- Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.
- Assist in the maintanence of the regulatory database, updating it regulatory and promptly as necessary.
- Overseeing the planning, coordination, and management of regulatory documentation activities

**REQUIREMENTS**:

- Bachelor's degree in a relevant field such as bioengineering or a related discipline.
- At least **1-2 years **' of experience in regulatory affairs in the medical devices industry.

**ESSENTIAL QUALITIES**:

- Problem-solving skills to navigate complex regulatory issues and find innovative solutions.
- Ability to prioritize tasks and manage multiple projects simultaneously.
- Collaboration skills to work effectively with cross-functional teams, including commercial, manufacturing, and quality assurance.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

  • Head of Regulatory Affairs

    7 days ago

    Singapore Keller Executive Search Full time

    The Head of Regulatory Affairs will be responsible for ensuring that our company complies with all relevant regulations and laws. This role requires a deep understanding of the pharmaceutical industry's regulatory environment and involves developing regulatory strategies, overseeing regulatory submissions, and liaising with regulatory bodies. Job...

  • Regulatory Affairs Executive

    5 days ago

    Singapore Superform Consulting Pte Ltd Full time

    Job Title : Regulatory Affairs Executive Location: Tuas **Salary**: $4500-$6000 Working Days: Mon -Fri Working Hours: 7.45AM-4.45 PM Job Duties - Prepare and maintain the registry of all products registered locally and internationally. - Prepare and maintain the markets regulatory requirements for implementation in the company. - Follow-up on any...

  • Regulatory Affairs Executive

    7 days ago

    Singapore Hays Full time

    **Your new company** Join one of the leading pharmaceutical company today! Excellent opportunities for learning in Regulatory Affairs work. **Your new role** - Communicate with regulatory authorities as well as overseas counterparts with regards to regulatory affairs matters such as product registrations, changes in existing products and renewals - Ensures...

  • Regulatory Affairs Executive

    2 days ago

    Central Singapore Emprego SG Full time

    **Location** - Singapore, Central Singapore**Job Type** - Permanent**Salary** - $4,000 - $7,000 Per Month**Date Posted** - 2 hours agoAdditional Details **Job ID** - 113486**Job Views** - 1Roles & Responsibilities **Our client is a Consumer Health MNC, one of the leading players in the sector. Due to business needs, they are now recruiting Regulatory...

  • Regulatory Affairs Executive

    2 weeks ago

    Singapore Hyphens Pharma International Limited Full time

    COMPANY DESCRIPTION **Listed on the Catalist board of the Singapore Exchange (SGX), Hyphens Group has a direct presence in Singapore (HQ), Vietnam, Malaysia, Indonesia and the Philippines, and is supplemented by a marketing and distribution network covering additional jurisdictions like Hong Kong, Myanmar, Brunei, Cambodia, Oman, Bangladesh, South Korea and...

  • Regulatory Affairs Executive

    4 hours ago

    Singapore FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD. Full time

    Full awareness of local Health Products and Medical Device Act and their regulations relevant to the business through regularly checking HSA websites and attending HSA briefings; - Communicate changes and new requirements to management; - Meet, discuss and negotiate with HSA regulators on matters pertaining to product registrations; - Have working knowledge...

  • Regulatory Affairs Professional

    2 weeks ago

    Singapore beBeeRegulatory Full time

    Regulatory Affairs Specialist RoleWe are seeking a skilled and detail-oriented Regulatory Affairs Specialist to support our regulatory activities.This role will involve assisting with the submission of applications and variations for clinical trials and marketing authorisation across all pipelines.Main Responsibilities:Submission Support: Assist with the...

  • Regulatory Affairs Executive

    4 hours ago

    Singapore Employment Vietnam Full time

    **Summary**: Our client is a UK-based multinational company specializing in the creation of original fragrances and flavors. They are seeking a talented individual to join their team as a Regulatory Affairs Executive Primary **Responsibilities**: - Provide technical documentation to our customers in a timely manner. - Advise customers on products...

  • Regulatory Affairs Executive

    1 day ago

    Singapore NESTLE SINGAPORE PTE LTD Full time

    **A day in the life of...** - Regulatory Compliance (Recipe check, regulatory input on label, label approval, communication materials) - Compliance Check & Review - Label-D System Implementation and Training - Inter Market Supply Product Brief (IMSPB) (SG as Importing Market) - Maintain Documentation - Support Regulatory Projects **What will make you...

  • Regulatory Affairs Executive, Apac

    2 weeks ago

    Singapore Symrise Full time

    **About Symrise AG** Symrise is a global supplier of fragrances, flavors, food, nutrition, and cosmetic ingredients. Its clients include manufacturers of perfumes, cosmetics, food and beverages, pharmaceuticals and producers of nutritional supplements and pet food. Its sales of € 3.8 billion in the 2021 fiscal year make Symrise a leading global provider....